DETAILED OFFICIAL ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Examiner Note
It is noted that all references hereinafter to Applicant’s specification (“spec”) are to the published application US 2023/0293850, unless stated otherwise. Further, any italicized text utilized hereinafter is to be interpreted as emphasis placed thereupon.
Information Disclosure Statement
The information disclosure statements (IDS) filed 24 January 2023 and 30 May 2025 are in compliance with 37 CFR 1.97 and have been considered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Blankenship et al. (US 2004/0020586; “Blankenship”), in view of Martin (US 2021/0290907; “Martin”) and Yasuaki et al. (JPH11-137509; “Yasuaki”) (copy and machine translation provided herewith; translation relied upon); optionally further in view of Quick et al. (US 2018/0361116; “Quick”).
Regarding claim 1, Blankenship discloses a tube formed from spirally wrapping, i.e. winding a sheet (40), e.g. long strip of expanded polytetrafluoroethylene (ePTFE) around a mandrel (41) wherein longitudinal edges of the wrapped sheet (i.e. of each wrap) abut one another or overlap one another in each layer; the tube comprises, e.g. two to about five layers of the wrapped sheet (one layer spanning the length of the mandrel) [Abstract; Fig. 4; 0006, 0010-0011, 0020-0021, 0024].
After the sheet is wrapped around the mandrel to form the desired number of layers, the resultant tube is heat fused, e.g. in an oven at or above the sintering temperature of the ePTFE, e.g. at about 350° C to about 390° C for about 10 to about 30 minutes, to bond the wrapped sheet at the abutting or overlapping locations [0024-0025]. Thereafter, the fused tube may be stretched, sintered, compacted, and then further sintered [0027]. The wall thickness of the resultant tube is from 0.002 in (50.8 µm) to about 0.005 in (127 µm) [0028]. The length of the tube may be, e.g. 0.5 to 6 cm (5 to 60 mm) (not limited thereto) [0028].
To illustrate the basis of the rejection, the tube depicted in Fig. 4 of Blankenship is reproduced hereinbelow, captioned as Figure 1.
PNG
media_image1.png
319
444
media_image1.png
Greyscale
Figure 1. Tube of Blankenship, depicting wrapping of sheet (40) around mandrel (41)
With respect to the difference(s) relative to the claimed invention, Blankenship is silent regarding the number of windings in at least one of the layers, per length of 10 mm (of the tube) in the longitudinal direction, not being constant.
Martin teaches that the pitch/angle of the helically/spirally wound layer(s) may vary along the length of the tube or over specific lengths thereof, in order to tailor specific properties of the tube or specific lengths thereof, such as rigidity/flexibility – in particular, the number of wraps per unit length of the layer(s) may increase or decrease, where less wraps per unit length corresponds to softer/more-flexible regions and more wraps per unit length corresponds to more-rigid/supportive regions [Figs. 2B, 2D, 10D; 0002, 0012-0013, 0079, 0083-0086, 0092, 0106, 0113, 0117, 0119]. Each wrap may overlap or be spaced from an adjacent wrap, and the tube is suitably heat-fused [0026-0028, 0079, 0092, 0097-0098, 0106]. To illustrate the foregoing, the tubes depicted in the aforecited Figures 2B and 2D of Martin are reproduced hereinbelow, captioned as Figure 2.
PNG
media_image2.png
586
620
media_image2.png
Greyscale
Figure 2. Tubes of Figs. 2B and 2D of Martin
Yasuaki teaches that by changing the winding pitch (spacing) and/or winding angle of the tape (27) in a layer along the lengthwise direction (longitudinal) of the layer, the rigidity of the tube may be tailored to achieve a distribution thereof in the lengthwise direction, such as a high rigidity section which transitions to a medium rigidity section which transitions to a flexible section, from the proximal to distal end of the tube [Fig. 2; 0012-0013, 0015, 0017, 0021-0022, 0027, 0029]. To illustrate the foregoing, the tube depicted in the aforecited Figures 2 of Yasuaki is reproduced hereinbelow, captioned as Figure 3.
PNG
media_image3.png
193
535
media_image3.png
Greyscale
Figure 3. Tube of Fig. 2 of Yasuaki
Quick teaches that by varying the width of the overlap (pitch) of adjacent windings of PTFE tape in a layer in the lengthwise direction of the tube, the stiffness may be varied in the lengthwise direction thereof, or regions having different stiffness may be formed [Abstract; 0024-0025, 0029-0031, 0033].
Blankenship, Martin, Yasuaki, and Quick each constitute prior art which is directly analogous to the claimed invention – tubes suitable for use as medical devices, e.g. catheters which are formed from wound polymeric tapes/strips/sheets.
In view of the combined teachings of Blankenship, Martin, and Yasuaki, and optionally Quick, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the tube of Blankenship by varying the winding pitch and/or winding angle – and thus the number of windings per unit length – of the sheet (40) along the lengthwise direction in at least one of the layers, continuously along the entire length thereof or in specific regions thereof, in order to alter/adjust the flexibility and/or rigidity/stiffness of the tube in said direction based on a predetermined end use of the tube.
Given that the tube may be up to, e.g. 60 mm long and the number of windings per unit length would have changed, e.g. continuously along the entire length (or alternatively in specific lengthwise regions thereof), it stands to reason, in accordance with the aforesaid modification(s), that the number of windings per 10 mm length in the longitudinal direction of the tube of Blankenship (hereinafter “modified Blankenship”) would have necessarily not been constant.
Further, regarding the limitation of the tube having “an endothermic peak in a range of 380° C ± 10° C” determined by DSC, it is noted that Applicant’s spec [0032, 0037, 0045, 0049] indicates that an unsintered, porous PTFE film is utilized, wherein the film is sintered at a temperature (e.g. 380° C) equal to or above the melting point of the porous PTFE, thereby obtaining a high-density PTFE film which exhibits the endothermic peak as stated/claimed.
Given that the ePTFE sheet (40) which forms the tube of modified Blankenship is initially porous and subsequently sintered at a temperature of about 350° C to about 390° C, thereby inclusive of temperature at or above the melting point thereof, the disclosure of Blankenship (as modified) encompasses embodiments of the tube which would have necessarily been sintered at 380° C or above and thereby would have necessarily exhibited an endothermic peak in a range of 380° C ± 10° C determined by DSC, as claimed, absent a showing of factually supported objective evidence to the contrary. See MPEP 2112(V); MPEP 2112.01(I) and (II); MPEP 2145; and MPEP 2145(I).
As such, the tube of modified Blankenship reads on, and renders obvious, the tube defined by each and every limitation of claim 1.
Regarding claim 2, in view of the grounds of rejection of claim 1 above, Blankenship is silent regarding at least one layer of the wrapped sheet (40) being spirally wound clockwise and at least one layer being spirally wound counterclockwise.
Martin teaches that the tube may include layers wound clockwise and (or) counterclockwise in order to produce directionally unbiased (or directionally biased) tubes which, when formed into medical devices such as catheters, are suited to specifically follow straight (unbiased) pathways or bent (biased) pathways of arteries or other body passageways [Fig. 2D; 0037, 0049, 0086].
In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the tube of modified Blankenship by spirally winding at least one layer of the wrapped sheet (40) in the clockwise direction and at least one layer of the wrapped sheet (40) in the counterclockwise direction, as taught by Martin, in order to form a directionally-unbiased or directionally-biased tube, respectively, specifically suited to follow straight or bent body passageways, respectively, when the tube is utilized (as intended based on the disclosure of Blankenship) as a catheter. As such, the tube of modified Blankenship would have comprised at least one layer of the wrapped sheet (40) spirally wound in the clockwise direction and at least one layer of the wrapped sheet (40) spirally wound in the counterclockwise direction, thereby reading on the tube defined by claim 2.
Regarding claim 3, the grounds of rejection of claim 1 above read on the tube defined by claim 3 – the overall wall thickness of the tube of modified Blankenship is from 0.002 in (50.8 µm) to about 0.005 in (127 µm). Given that the wall thickness is formed from, e.g. two to five layers, the average thickness of [at least] one layer may range from about 10.2 µm (i.e. 50.8/5 layers) to about 64 µm (127/2 layers), of which is within the claimed range of 3 µm or more and 75 µm or less (MPEP 2131.03; MPEP 2144.05(I)).
Regarding claim 4, in view of the grounds of rejection of claim 1, wherein each individual winding of the sheet (40) abuts or overlaps the adjacent winding, where the number of windings per length (e.g. 10 mm) in the longitudinal direction of the tube is not constant, where the layer(s) of the tube formed from the wound sheet (40) are sintered and heat-fused to form the wall at a temperature which is within/at the range disclosed in Applicant’s spec, and where the material of the sheet (40) is ePTFE, wherein all of the foregoing elements are substantially identical or identical to the claimed and disclosed tube, it stands to reason that the tube of modified Blankenship would have necessarily exhibited a tensile strength of 100 N/mm2 or more determined in accordance with JIS K7127-1999, as claimed, absent a showing of factually supported objective evidence to the contrary. See MPEP 2112(V); MPEP 2112.01(I) and (II); MPEP 2145; and MPEP 2145(I).
Regarding claims 5 and 6, the grounds of rejection of claim 1 above are incorporated herein by reference (not repeated for sake of brevity). In addition to the prima facie case of obviousness established above and incorporated herein, it would have also been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the tube of Blankenship (as modified above) by increasing and/or decreasing the winding angle and/or winding pitch of the wrapped polymeric sheet (40) through routine experimentation – over any numerical range or percentage range of said winding angle and/or winding pitch (i.e. any number or percentage of windings per unit length, e.g. 10 mm or more), e.g. from greater than 0.1 windings/10 mm or from greater than 10%, respectively, up to any number of windings/10 mm or any percentage, respectively – in order to having tailored/optimized the desired degree of flexibility/rigidity distribution along the lengthwise direction of the tube or specific region thereof. See MPEP 2144.05(II)(A) and (II)(B); see MPEP 2144.05(III)(A); see MPEP 716.02.
Applicant is respectfully directed to the aforecited MPEP sections 2144.05(II)(A) and (II)(B), which indicate that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation – the normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. A change in form, proportions, or degree ‘will not sustain a patent’ – it is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.
As such, in accordance with the aforesaid modification(s), the winding pitch and/or winding angle of the [at least] one layer of the wrapped sheet (40) of the tube of modified Blankenship would have necessarily been varied over the claimed difference in maximum versus minimum number of windings of at least 0.1 windings/10 mm or more and necessarily over the claimed difference in maximum versus minimum number of windings of at least 10% or more, thereby reading on, and rendering obvious, each tube defined by the respective limitations of claim 5 and claim 6, absent a showing of objective evidence of criticality or an unexpected result associated with the claimed ranges.
Regarding claim 7, in view of the grounds of rejection of claim 2 above, the grounds of rejection of claim 3 above are incorporated herein by reference and – taken in view of the grounds of rejection of claim 2 – read on the tube defined by claim 7.
Regarding claim 8, in view of the grounds of rejection of claim 2 above, the grounds of rejection of claim 4 above are incorporated herein by reference and – taken in view of the grounds of rejection of claim 2 – read on the tube defined by claim 8.
Regarding claim 9, in view of the grounds of rejection of claim 3 above, the grounds of rejection of claim 4 above are incorporated herein by reference and read on the tube defined by claim 9.
Regarding claim 10, in view of the grounds of rejection of claim 7 above, the grounds of rejection of claim 4 above are incorporated herein by reference and – taken in view of the grounds of rejection of claim 7 – read on the tube defined by claim 10.
Pertinent Prior Art
The following constitutes a list of prior art which are not relied upon herein, but are considered pertinent to the claimed invention and/or written description thereof. The prior art are purposely made of record hereinafter to facilitate compact/expedient prosecution, and consideration thereof is respectfully suggested.
US 2003/0050528 to Shannon et al. – teaches that helically wound PTFE filaments may be wound more tightly (lower angle, higher pitch) at the proximal and distal ends of the tube relative to the middle section therebetween in order to form a supported tube [Fig. 3; 0043-0044]
US 2008/0097301 to Alpini et al. – teaches that the wrap angle may change such that a single pass, i.e. single wrapped layer may include two or more wrap angles [Figs. 5-6, 8; 0025-0029, 0041]
US 2014/0207114 to Jimenez et al. – teaches that by progressively changing the pitch or helical period (picks per inch), a continuous incremental compliance from proximal to distal end may be achieved [Fig. 7; 0009, 0013, 0032, 0034, 0048]
US 5,454,795 to Samson – teaches that by varying the number of winds per inch, the stiffness in the lengthwise direction of the tube may be tailored [Fig. 4; col. 7–col. 8]
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Michael C. Romanowski whose telephone number is (571)270-1387. The Examiner can normally be reached M-F, 09:30-17:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Aaron Austin can be reached at (571) 272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL C. ROMANOWSKI/Primary Examiner, Art Unit 1782